Customized support for your unique analytical program
Our team designs robust testing approaches that not only meet ICH and FDA standards, but also deliver the clarity and consistency your program needs to progress without delay.
We specialize in potency assays, biomarker analytics, and complex method transfers for biologics, cell therapies, and advanced modalities - ensuring your analytical toolkit evolves alongside your product.
How we work
Whether you're preparing your BLA release and stability assay validation packages or resolving issues with assay variability, our team builds analytical solutions that are fit for phase, inspection-ready, and built for long-term use. We translate regulatory guidelines into tools that work in real-world development environments.
We support clients across every stage of product development by providing:
Assay development, optimization, and regulatory validation aligned with FDA and ICH requirements
Potency and biomarker assay design that reflects product mechanism and supports comparability
Analytical gap analyses to strengthen regulatory filings and stability programs
Method transfer planning and oversight to ensure continuity across sites and CROs
Case Study
Method transfer for monoclonal antibody program
A biopharma client encountered serious delays transferring analytical methods to a new CRO. Harmony assessed the technical and operational gaps, restructured the transfer process, and implemented a stakeholder communication plan.
$1M
in reduced testing costs annually
6-month acceleration of the method transfer timeline
$1M in immediate savings
Long-term testing model established for commercial readiness
Regulatory Affairs Lead
Biologics Manufacturer
"The validation packages for our BLA-including over 30 methods-were reviewed during a week-long FDA pre-approval inspection. The investigator had no comments. That level of preparation speaks volumes about Harmony's quality and regulatory rigor."
FAQ
In most cases, yes - particularly for complex biologics and advanced therapies. A well-designed in vitro potency assay should, to the extent possible, reflect the product's mechanism of action in vivo. As development advances, this assay becomes essential not only for characterizing product performance but also for supporting comparability studies, stability programs, and regulatory submissions across dosage forms and manufacturing sites.
Harmony brings deep expertise in the development, transfer, and validation of potency assays across a wide range of therapeutic modalities. We partner with clients to design fit-for-purpose assays that meet evolving regulatory expectations and support robust, scalable product development.
A qualified assay is typically used in earlier phases of development, where key performance characteristics-such as precision, accuracy, range, linearity, and detection/quantitation limits-have been evaluated to establish the method's suitability for its intended use. At this stage, acceptance criteria are generally broader and may allow for more variability, as the method is still being refined.
A validated assay, by contrast, meets the full requirements outlined in ICH and regulatory guidelines. Validation is conducted using a predefined, prospective protocol and includes a thorough assessment of all critical parameters. Acceptance criteria are scientifically justified and supported by historical assay performance. Where applicable, stability-indicating capability, robustness, and system suitability are also rigorously evaluated to ensure consistent long-term performance.
At Harmony, we provide strategic, phase-appropriate guidance to ensure your analytical methods are aligned with regulatory expectations and are appropriately qualified or validated to support your development and submission milestones.